Position Summary:
The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality. The Quality Reviews are used to evaluate the completeness status of study TMFs and are critical to ensuring TMFs are maintained in an audit-ready manner. The Quality Review Specialist will be assigned responsibility for the less complex and/or smaller studies in the Precision portfolio.
Essential functions of the job include but are not limited to:
Performs periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality
Ensures that TMF documentation related to periodic TMF Quality Reviews is generated and filed in the TMF.
Informs the TMF Lead if the TMF is not updated with the information related to countries, sites, contacts and applicable TMF document requirements.
Supported by Manager, monitors and escalates to the TMF Lead document processing issues and inconsistences, missing/incorrect documents filed by the Functional Leads, non-response of the Functional Leads related to periodic Quality Review requests or questions.
During periodic Quality Reviews, supports updates to expected documents and opening of placeholders in TMF, where needed.
Where possible, identifies potential training needs for all team members working in the TMF to encourage high quality and consistent maintenance of the TMF.
Supported by Manager, identifies and escalates to TMF leadership studies at serious risk based on poor quality.
Qualifications:
Minimum Required:
Bachelor’s degree (or its international equivalent) + 2 years of related experience
Other Required:
Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
Experience with eTMF systems and vendors
Working knowledge of FDA & ICH/GCP regulations and guidelines
Skills:
Demonstrates solid interpersonal skills
Ability to identify issues and escalate appropriately and effectively
Good organizational skills, time management, and ability to coordinate workload and meet established deadlines
Competencies
Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
Communicates both verbally and in written form in an efficient and professional manner
Demonstrates values and a work ethic consistent with Precision Values and Company Principles
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.